Events

Device Recall VERO 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    73436
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1308-2016
  • 사례 시작날짜
    2016-03-07
  • 사례 출판 날짜
    2016-03-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144310
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Accelerator, linear, medical - Product Code IYE
  • 원인
    In rare cases the vero/mhi-tm2000 operator console could set an incorrect gantry angle for the first beam of an imrt treatment if certain specific conditions are met. if gantry angle for the first beam of imrt is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.
  • 조치
    A Field Safety Notice dated March 2, 2016, was sent to all affected customers via e-mail on March 7, 2016. The Field Safety Notice informed users of the problem and provided a safe workaround until corrected software is available. The correction will be free of charge and a Customer Service Representative will contact all affected customers to schedule its installation. Customers with questions were advised to contact their Customer Service Representative.

Device

Device Recall VERO
  • 모델명 / 제조번호(시리얼번호)
    Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including New York, Texas, Florida, and Ohio
  • 제품 설명
    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator || MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
  • Manufacturer
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Manufacturer

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
  • 제조사 주소
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA Japan
  • 제조사 모회사 (2017)
    Mitsubishi Heavy Industries Ltd.
  • Source
    USFDA